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Stereotactic Body Radiation Therapy for Breast Cancer

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

SBRT

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.

Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment.

Primary breast and axillary surgery not recommended/performed due to any of the following:

distant metastatic disease
unresectable T4 disease and/or
medically inoperable and/or
patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent.

Exclusion Criteria:

Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease >= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy > 50% of the ipsilateral whole breast volume.

Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g.

scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).

Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol

Sites / Locations

Sunnybrook Odette Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT to the Primary Breast Tumour

Arm Description

SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.

Outcomes

Primary Outcome Measures

Acute toxicity

Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0

Secondary Outcome Measures

Breast Symptom Scores

Patient reported breast symptom scores for bleeding, discharge and odour measured on a scale from 1 (no symptoms) to 10 (worst possible/continuous symptoms) using the Visual Analogue Scale tool

Patient Reported Quality of Life

Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires

Patient Reported Quality of Life

Patient reported quality of life measured using the VES13 questionnaire.

Patient Reported Pain Level

Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain

Tumour Response Rate

Measured on follow-up MRI or CT imaging using RECIST criteria

Full Information

NCT ID

NCT03585621

First Posted

June 19, 2018

Last Updated

May 5, 2022

Sponsor

Toronto Sunnybrook Regional Cancer Centre

1. Study Identification

Unique Protocol Identification Number

NCT03585621

Brief Title

Stereotactic Body Radiation Therapy for Breast Cancer

Official Title

A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 17, 2018 (Actual)

Primary Completion Date

April 1, 2023 (Anticipated)

Study Completion Date

July 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Toronto Sunnybrook Regional Cancer Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Sequential dose escalation design

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT to the Primary Breast Tumour

Arm Type

Experimental

Arm Description

SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.

Intervention Type

Radiation

Intervention Name(s)

SBRT

Other Intervention Name(s)

SABR

Intervention Description

Each radiation treatment plan will be customized to the patient and tumour in order to deliver highly conformal, conebeam CT guided SBRT radiotherapy in 4 fractions delivered over 2-4 weeks.

Primary Outcome Measure Information:

Title

Acute toxicity

Description

Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0

Time Frame

12 weeks post treatment

Secondary Outcome Measure Information:

Title

Breast Symptom Scores

Description

Patient reported breast symptom scores for bleeding, discharge and odour measured on a scale from 1 (no symptoms) to 10 (worst possible/continuous symptoms) using the Visual Analogue Scale tool

Time Frame

2 years post treatment

Title

Patient Reported Quality of Life

Description

Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires

Time Frame

2 years post treatment

Title

Patient Reported Quality of Life

Description

Patient reported quality of life measured using the VES13 questionnaire.

Time Frame

2 years post treatment

Title

Patient Reported Pain Level

Description

Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain

Time Frame

2 years post treatment

Title

Tumour Response Rate

Description

Measured on follow-up MRI or CT imaging using RECIST criteria

Time Frame

2 years post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology. Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment. Primary breast and axillary surgery not recommended/performed due to any of the following: distant metastatic disease unresectable T4 disease and/or medically inoperable and/or patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent. Exclusion Criteria: Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease >= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy > 50% of the ipsilateral whole breast volume. Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease). Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Danny Vesprini, MD, FRCPC

Phone

4164804806

Danny.Vesprini@sunnybrook.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Merrylee McGuffin, MSc, MRT(T)

Phone

4164806100

Ext

85454

Merrylee.McGuffin@sunnybrook.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danny Vesprini, MD, FRCPC

Organizational Affiliation

Sunnybrook Health Sciences Centre, University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Odette Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danny J Vesprini, MD, FRCPC

Phone

416-480-4806

danny.vesprini@sunnybrook.ca

First Name & Middle Initial & Last Name & Degree

Merrylee M McGuffin, MSc, MRT(T)

Phone

416-480-6100

Ext

85454

Merrylee.McGuffin@sunnybrook.ca

First Name & Middle Initial & Last Name & Degree

Danny J Vesprini, MD, FRCPC

First Name & Middle Initial & Last Name & Degree

Claire McCann, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Stereotactic Body Radiation Therapy for Breast Cancer

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